Dietary Intervention for Gestational Diabetes

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Gestational DiabetesDietary Intervention - Behavioral
Eligibility
18+
Female
What conditions do you have?
Select

Study Summary

This trial will assess the impact of a culturally tailored, personalized nutrition intervention on glycemic response to an oral glucose load in high-risk pregnancies of South Asian women.

Eligible Conditions
  • Gestational Diabetes

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

5 Primary · 8 Secondary · Reporting Duration: up to 1 year post-partum

3 months
Gestational diabetes mellitus
Glucose area-under-the-curve (glucose AUC)
Maternal blood pressure
Maternal pregnancy complications
area-under-the-curve of glucose
gestational diabetes mellitus
4 months
Cesarean section
Shoulder dystocia
birth length
birthweight
completeness of oral glucose-tolerance test (OGTT) measure
sum-of-skinfolds
5 months
acceptability of the intervention to the participants
study completion rate
Year 1
infant mortality

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Control
1 of 2
Dietary Intervention
1 of 2

Active Control

Experimental Treatment

190 Total Participants · 2 Treatment Groups

Primary Treatment: Dietary Intervention · No Placebo Group · N/A

Dietary Intervention
Behavioral
Experimental Group · 1 Intervention: Dietary Intervention · Intervention Types: Behavioral
Control
Behavioral
ActiveComparator Group · 1 Intervention: Control · Intervention Types: Behavioral
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dietary Intervention
2014
Completed Phase 2
~2550

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 1 year post-partum

Who is running the clinical trial?

Hamilton Health Sciences CorporationOTHER
344 Previous Clinical Trials
272,041 Total Patients Enrolled
Population Health Research InstituteOTHER
143 Previous Clinical Trials
669,037 Total Patients Enrolled
McMaster UniversityLead Sponsor
801 Previous Clinical Trials
1,727,667 Total Patients Enrolled
Russell J de Souza, ScDPrincipal InvestigatorMcMaster University

Eligibility Criteria

Age 18+ · Female Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a low diet quality.
References